FTC Proceeds with Raw Power Grab on Health Claims—In Effect Thumbing Its Nose at Congress

Last year, an administrative law judge (ALJ)* for the Federal Trade Commission upheld the pomegranate juice manufacturer’s right to make what the FDA would call structure/function claims in ads. Structure/function claims include statements such as “calcium helps build bones.” They don’t directly talk about curing a disease. At the same time, the ALJ found that some of the company’s claims went too far (specifically where they claimed the juice could help heart disease, prostate cancer, and erectile dysfunction).

Because the ALJ’s decision was a partial victory for both POM Wonderful and the FTC, both sides appealed, which necessitated a ruling from the FTC as a whole. Last Wednesday, the Commission took a much more unreasonable line. It found that thirty-four of POM’s forty-three claims were implied disease claims—fifteen more than the ALJ had found. The full Commission further ruled that a double-blind random-controlled trial (RCT) is required for any “efficacy” claim and two double blind RCTs for any claim that might seem to be related to a disease. The $35 million on peer-reviewed scientific research previously spent by POM was brushed aside because the studies were not RCTs, which are commonly used for drug testing.

This is a major one–two punch. The FTC is being draconian about what it considers an implied disease claim. One commissioner noted in remarks accompanying the decision: “It is difficult to imagine any structure/function claims that POM could associate with its products in the marketplace without such claims being interpreted, under the FTC precedent set in this case, as disease-related claims.”

In making these judgments, the agency has relied on what is legally called its own “net impression,” i.e., totally subjective judgment, and has ignored the ALJ’s request for a higher standard of “extrinsic evidence,” the sort of evidence that would come for example by testing how consumers actually interpret a label.

The agency is also requiring the hugely expensive pharmaceutical standard of the double-blind RCTs. As we have often noted, companies do not usually attempt RCTs because of their expense, unless they hold a patent on the substance being tested. And it is not possible to patent natural substances such as food. The FTC understands this. In effect, they are saying that food manufacturers will not be allowed to talk about health benefits, period. It is a complete gag order.

The ruling also blurs the line between the FTC and the FDA. The double-blind RCT for disease claims is an FDA labeling standard for drugs. The FTC is supposed to regulate advertising, not decide what is a drug. Its mandate is to ensure that advertisements are not deceptive or misleading—something that certainly does not require the pharmaceutical RTC standard! Now the FTC is unnecessarily and arbitrarily deciding to use an FDA drug standard for disease claims in advertising. Some industry observers even wonder whether the FDA has asked the FTC to do this because the FDA would not be able to go this far on its own.

There is absolutely no statute justifying this. It is making up law without congressional approval. Congressman Henry Waxman (D-CA) in particular has already tried and failed to give the agency the power to do this—in a sneaky and underhanded way. You may recall that in 2010, Waxman tried to slip an amendment into a totally unrelated bill. That amendment, which was intentionally written in obscure language that nobody but an expert could understand, would have given the FTC expanded powers and rulemaking authority, giving them the power to create new kinds of regulations without going back to Congress. (It lost that authority in the 1980s because Congress thought the FTC was abusing it. How ironic.) With your help, the amendment failed. Having in effect been told no by Congress, the agency is just going ahead anyway, seemingly on a case-by-case basis, creating regulations with no legal basis.

Who benefits from such a change in policy? Just follow the money. If the FTC prevails in requiring double-blind RCTs, only pharmaceutical companies will be able to make health claims on their patented and FDA-approved products.

The Commission’s decision directly affects only POM Wonderful (along with all its affiliated companies despite the fact that POM was the only company at issue here!). But it sets a powerful precedent and makes it clear that the FTC will try to enforce this as widely as possible.

Food, drug, and constitutional law attorney Jonathan Emord called the decision “arbitrary and capricious” and said, “The breadth of [the FTC’s new two-RCT] requirement is truly astonishing….After today’s decision, the health marketplace will be dumbed down considerably to the detriment of health conscious consumers….In the end, that will mean a loss in public health as there will now be a multi-million dollar entry fee imposed on any who would wish to convey a health benefit to consumers in the market.”

This is just one more reason we need to pass the Free Speech about Science Act, which would allow natural product companies to cite peer-reviewed science in their advertising.

For now, we need to let Congress know that the FTC is trying to make an end run around the legislative process. Having been turned down by Congress, the FTC is proceeding as though empowered anyway. Action Alert! Let’s be sure that Congress understands that voters are watching, and voters care about this example of agency lawlessness. Please take action now.

* An administrative law judge does the initial hearing of cases in the FTC’s administrative complaint proceeding. The ALJ issues the initial decision setting out relevant findings, explains the legal standard, applies the law, and issues an order. Only if the ALJ’s ruling is appealed does the case go before the full Commission.

14 Responses to “FTC Proceeds with Raw Power Grab on Health Claims—In Effect Thumbing Its Nose at Congress”

Since the FTC thinks that food product companies should conduct two double-blind random-controlled trials for any claim that might seem to be related to a disease, and completely brushes aside the $35 million that POM spent on peer-reviewed scientific research, POM should start a new advertising campaign that goes something like this:

“We are definitely not making any health claims about our pomegranate juice. The FTC has told us that doing so would make our juice turn into an unapproved drug. Since we are a law-abiding company that believes in truth, we want to make it very clear that we specifically are not saying that medical university studies have shown that drinking a glass of pomegranate juice daily helps restore heart function, builds stronger bones, (….etc.). So please don’t get the idea that we are agreeing with or endorsing those studies; all we are claiming is that our product tastes great!”

I agree with everyones comment, I was just reading over the FDA guidelines regarding labeling for skincare products .. We are a manufacture of children’s skincare products and want to use organic essential oils in our spa products , the benetfits are fabulous , they have been around for thousand of years ..but the FDA, says if we tell the consumer the benefits of herbs or essential oils then that is a drug and we have to be regulated. Crazy , let them stick to the drugs they approve , that end up killing us ..and leave the Natural stuff alone . thanks

Christina, try this: On your product label mention that you use organic ingredients to avoid the following documented negative effects of common chemical ingredients found in similar non-organic products:
skin rash
cancer
nausea
endocrine system disruption
etc…

That way you don’t make any particular health claims about your good ingredients, you just list what bad stuff it won’t do. Kind of uses the FDA’s own regulations against them in a truthful way!

We have a God given right to be informed of the potential benefits of any product, even if it us not scientifically proven. We also have the same God given right to know if any product contains anything that is not purely natural and safe such as GMO products.

Please work to pass the Free Speech about Science Act. While America spends the most money per capita on healthcare, we come in dead last on results among the industrialized nations. These two thoughts are connected. Citizens need to know the relationship between foods and health.

Until we fire all the biotech and pharmaceutical executives that comprise the FDA, we will continue to have such abuses as reported here. Biotech ex-perts promote chemicals that poison our food supply so pharmaceutical companies have more so-called diseases for which to make chemical vaccines (that contain mercury). Both industries work in concert with each other for that brass ring..all the money! As long as biotech is allowed to feed us tainted food and we get ill from it, big pharma has an open list of clients for their chemical drugs. Now enter, ObamaCare – This Act mandates vaccines for your children to the point of placing “health clinics” near and in your schools. Why? So they can make sure our children will be injected with enough drugs to render them non-combatant, i.e. doesn’t question the system. This will make it much easier for enforcers of the NDAA to herd people into the holding pens before putting you on a train to the nearest FEMA camp “for your own protection”. Once you are in a FEMA camp, combatants will disappear, elderly will be eliminated and the younger, sedated crowd will be working on NDAA work parties. This is Obama’s plan for We The People. The elite have decided there are too many humans in this world, so they have made themselves judge, jury & executioner to decide who lives and who does not. Make no mistake, they do it for the money & power. Turn the clock back, Rome’s executions to Egypt’s work parties. This is their plan for us. I, for one, will not allow this to happen to my family. We will grow our own food and trade with the non-GMO dairy & grain farmer. I will make our own medicinal remedies like my Native American Mothers before me. I will teach these skills to my children and grandchildren so they can make a better life for themselves than being a slave in a FEMA camp.

What do you mean that foods can’t be patented? Monsanto owns almost every soybean, corn and canola seed on the planet! Besides, the FDA is a paper tiger owned by big-business. Otherwise, drugs like Darvon, Darvoset, Avastin, Chantix, Paxil, Zoloft, Fasamax, Actose, Yaz, Yazmin, Lipitor, Pradaxa, vaginal pelvic slings, Propecia, etc. that have actually supposedly passed the RCT tests are being recalled. Perhaps they should be held to the same standards…their claims were proven to be defective and incorrect…with side effects that actually killed people and yet, their drugs are still on the market!

This is exactly the same thing that is happening with the EU and Europeon countries. It appears to be a war on giving information to the public of the benefits of natural products. All under the guise of consumer protection from unfounded claims. What it is actually doing in effect is giving no information and people will seek the information they require in unregulated places such as the internet. Defeating their object of protecting consumers anyway. I believe large pharmaceutical companies are behind this in collusion with food regulators.

EU-style law-making has reared it ugly head on US shores – and the First Amendment is now not only gravely threatened, it is being trampled upon by the FTC. The requirement for RCTs is madness and is down to an inappropriate transference of principles that have long used for drug licensing. Foods and food ingredients don’t lend themselves well to RCTs because you ca’t not expose your control groups to food. Also, if food/supplement companies do studies with diseased populations with the intention of demonstrating an effect, they might find—like we do in Europe—that not only are the studies rejected because they don’t involve healthy people, they might be used as evidence that the companies are selling unlicensed drugs. Jonathan Emord – we’re relying on you to fix this!

My comments at the end of your email are as follows:
It is my perception that in this case you have a group of concerned citizens closely monitoring executive power grabs by one agency. You are confronted by an Executive which has essentially encouraged all of its agencies to write their regulations as they wished you had passed the legislation. ANH has described this particular instance as “an end run”. The agencies sometimes elect to simply run over the legislation, and other times simply ignore the content of the legislation, because they have no evidence that the legislative branch of government cares enough to actually pay attention to the regulations. I’m not sure whether the Founders made assumptions about the integrity of legislators that are no longer true, or their assumptions about the Chief Executive that have failed. What do you think?

I think you are performing a valuable service. While I would not want to dilute your efforts in any way, every cotton-pickin’ agency, department, bureau, & section of the Executive branch of govt needs a group to monitor their regulations and other activities; to inform Congress of all examples of excess, and expose the activities/inactivities of both sides to the light of day.You strike me as being pretty darned good at those functions. You could probably magnify your contribution by providing a liaison office to help like-minded groups deal with other recalcitrant agencies.

I was under the impression that it was ruled ,this last year, that a company was now considered “people” thus their right to donate to candidates for office, expessing their views on a subject( Free Speech). Does that not include all people (companies) . I would think that the authorities would have no right to limit a persons (company’s) right to express their viewpoint about any matter, unless it was proven untrue, as in libel and slander laws The burden of proof would fall on the authorities or the accusing party, proving the claim was false While I don’t agree that a company should be allowed to throw an election in their favor opposing the will of most people, I do believe they should be allowed to market their products without interference unless they have been proven to be ripping off their customers with an inferior product or false information about their product . Which brings us to … Why are the drug companies allowed to delberately mislead patients ( and doctors) about the harm done by their products ( 100,000 +deaths per year, with unknown totals of adverse reactions) , yet basically be allowed to pursue frivilous, bankrupting claims against harmlless products and the companies producing them. . These accusations shoul never be allowed to be brought. We , the people , have the right to voice our opinion and educate ourselves as we choose and about subjects we choose. We are not fools , at least , most of us, and what we really need is for the government to protect us from the very companies that are bringing these charges, only to protect their profits while totally disregarding the horrific damages done by their own product.

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